Back to the drawing board for Lykos' MDMA therapy

The FDA declined to accept Lykos Therapeutics' application for MDMA as a treatment for PTSD, as stated in a letter dated August 9 and released by the company. Lykos, the for-profit arm of MAPS, expressed disappointment but plans to continue seeking approval. That same day, three peer-reviewed studies were retracted. The FDA did not entirely rule out future approval but requested additional information from Lykos.

Study at a glance

Abstract

The Food and Drug Administration (FDA) did not accept the application of Lykos Therapeutics for MDMA as a treatment for post‐traumatic stress disorder (PTSD). In a letter dated Aug. 9 and released by Lykos Therapeutics, the for‐profit arm of the Multidisciplinary Association for Psychedelic Studies (MAPS), the company stated that it is disappointed in the FDA response, but that it intends to pursue the goal of approval. This announcement was followed by the retraction of three peer‐reviewed studies on Aug. 9 as well. The FDA did not completely reject the idea of ever approving MDMA, but asked Lykos for more information.